MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Loose or Intermittent Connection (1371); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx2943 showed no other similar product complaint(s) from this lot number.

Event Description

Nurse on cardiology dep placed a powerglide pro under supervision of a clinical specialist from bd.Get access on first attempted and have blood return.Advance the guidewire into the vein, it is a resistant, so she pull the wire back and lower the angel of the needle.The needle tip seems to be in the middle of the vein.Advance the guidewire, no resistant.Advance the catheter about 5 cm, then it not able to advance it more.They decided to end the insertion and pull out the needle.At this point they see that the wire is loosened from the device, and a part of it is visible in the insertion place.The nurse pull it out.The wire is damaged, the part that has been in the patient has spun up, is long and crooked.The device will be sent in.After inspection it seems it is complete and nothing is left in the patient's vein.

Manufacturer Narrative

The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.The sample was received with the catheter detached from the needle and the safety mechanism engaged.Usage residues were observed throughout the sample.A fragment of guidewire was received loose.The fragment included the distal weld tip.Microscopic inspection of the break in the wire revealed a granular fracture surface.A region of increased luster was observed.Curved shape was observed in the vicinity of the break.Inspection of the needle bevel revealed outward flaring mechanical damage along the proximal edge.The guidewire and needle damage were consistent with damage initiated by retraction of the needle against the needle bevel.Such damage can occur if guidewire retraction is attempted following insertion at a steep angle.A lot history review (lhr) of recx2943 showed no other similar product complaint(s) from this lot number.

Event Description

Nurse on cardiology dep place a powerglide pro under supervision of a clinical specialist from bd.Get access on first attempted and have bood return.Advance the guidewire into the vein, it is a resistant, so she pull the wire back and lower the angel of the needle.The needle tip seems to be in the middle of the vein.Advance the guidewire, no resistant.Advance the catheter about 5 cm, then it it not able to advance it more.They decide to end the insertion and pull out the needle.At this point they see that the wire is loosened from the device, and a part of it is visible in the insertion place.The nurse pull it out.The wire is damaged, the part that has been in the patient has spun up, is long and crooked.See attached picture and the device will be sent in.After inspection it seems it is complete and nothing is left in the patients vein.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8462066
• MDR Text Key: 140452982
• Report Number: 3006260740-2019-00717
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741138621
• UDI-Public: (01)00801741138621
• Combination Product (y/n): N
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6F120100
• Device Lot Number: RECX2943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1